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FDA 510(k)

Precision Point Biopsy Needle Guide

K-Number: K160414 · 2016-08-01

ApplicantCorbin Clinical Resources, LLC
Decision Date2016-08-01
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Precision Point Biopsy Needle Guide is the device name listed in this FDA 510(k) record. The listed applicant is Corbin Clinical Resources, LLC. It received FDA 510(k) clearance on 2016-08-01 under 510(k) number K160414. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Precision Point Biopsy Needle Guide?

Precision Point Biopsy Needle Guide is a medical device that received FDA 510(k) clearance on 2016-08-01. The listed applicant is Corbin Clinical Resources, LLC. The 510(k) number is K160414.

When did Precision Point Biopsy Needle Guide receive FDA 510(k) clearance?

Precision Point Biopsy Needle Guide received FDA 510(k) clearance on 2016-08-01, under 510(k) number K160414.

Who is the listed applicant for Precision Point Biopsy Needle Guide?

The FDA 510(k) record lists Corbin Clinical Resources, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Precision Point Biopsy Needle Guide?

The FDA product code for Precision Point Biopsy Needle Guide is ITX.

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Other records listing Corbin Clinical Resources, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K160423Perineologic Access Needle

Related Devices (Code: ITX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261170BA-004CCFujifilm CorporationK254143EM-TECH Passive Ultrasound Probe StrapEM-TECH Solutions, Inc.K260161SmartGuide Disposable Guides and GridsUC-CARE , Ltd.K262474ND Needle Guidance SystemAccurate Access, LLCK261014Accuro® 3S Needle Guide KitRivanna Medical, Inc.K250883ULTRASONIC PROBE UM-3R (UM-3R); ULTRASONIC PROBE UM-G20-29R (UM-G20-29R)Olympus Medical Systems Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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